その他の機能 > Windchill Quality Management Solutions > Unique Device Identification > Working with Unique Device Identification > Completing the UDI Super Set Form
  
Completing the UDI Super Set Form
• For UDI templates, this is the New UDI Template or Edit UDI Template window.
• For UDI Super Set, this is the Edit UDI window.
Set Attributes
Complete the following fields in the FDA Attributes section in Set Attributes step.
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The system completes some information in advance.
• If you are editing a UDI Super Set, the system completes the Name and Number fields.
• If you created a UDI Super Set from a part, the system completes some fields with information from the part.
• If you created the UDI Super Set using a UDI Super Set template, the system completes some fields with information from the template.
1. Under Device Identifier Information, complete the following fields:
Attribute
Description
Device Identifier Issuing Agency
Select the name of the issuing agency of the device identifier:
• GS1–GTIN
• HIBCC
• ICCBBA
Device Identifier
Enter a primary device identifier number. This number is the primary lookup for a medical device product. It must meet the requirements to uniquely identify a device through its distribution and use.
The primary DI number is located on the base package, which is the lowest level of a medical device containing a full UDI.
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This field is required for creating or editing UDIs.
Unit of Use Device Identifier
Enter a unit of use device identifier number. For example, a unit of use identifier would be assigned to an individual electrode when the electrode is distributed in a package of 10. This associates the use of a device with a patient.
Direct Part Marking Device Identifier
Enter a direct part marking device identifier, if the identifier is different from the primary device identifier. This identifier is marked directly on the medical device. This only applies to devices subject to direct marking requirements as described under 21 CFR 801.45.
Exempt from Direct Part Marking
Select Yes if the company can claim that the product is exempt from direct part marking requirements as described under 21 CFR 801.45.
2. Under Device Product Information, complete the following fields:
Attribute
Description
Labeler DUNS
Enter the DUNS number. This is the business number issued by Dun & Bradstreet (D&B) that matches the company name on the device label.
Brand Name
Enter the proprietary brand name of the medical device as used in product labeling or in the catalog. This information can appear in the following ways:
• On a label attached to a durable device
• On a package of a disposable device
• In labeling materials of an implantable device
Model Number
Enter the model number or version number found on the device label or accompanying packaging.
Catalog Number
Enter the catalog, reference, or product number found on the device label or accompanying packaging.
Device Description
Enter a detailed description of the device. Include additional relevant information about the device that is not already captured as a distinct GUDID data attribute.
3. Under Sterilization and Device Characteristics, complete the following fields:
Attribute
Description
Packaged Sterile
Select Yes if the medical device is free from viable microorganisms. If you select Yes, complete the Sterilization Method section in the Table Data step.
Requires Sterilization
Select Yes if the medical device requires sterilization before use. If you select Yes, complete the Sterilization Method section in the Table Data step.
Contains Latex
Select Yes if the medical device or packaging contains natural rubber that would come into contact with a person as described under 21 CFR 801.437.
Selecting Yes indicates that the device label or packaging contains one of the following statements:
• "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
• “This Product Contains Dry Natural Rubber."
• “Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
• "The Packaging of This Product Contains Dry Natural Rubber."
Labeled as ‘Not made with latex’
Select Yes if natural rubber latex was not used to manufacture the medical product or container. This only applies to devices that are not regulated by 21 CFR 801.437.
Contains Human Tissue
Select Yes if the device contains human tissue. This indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3.
Kit Product
Select Yes if the product is a kit. This indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products (including medical devices) that are packaged together to achieve a common intended use and are being distributed as a medical device.
Combination Product
Select Yes if the product is a combination product according to the FDA. This indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). At least one of the products in the combination product must be a device.
Single-Use
Select Yes if the product is a single-use (consumable or disposable) product.
Prescription Use
Select Yes if the product requires a prescription.
Over the Counter Use
Select Yes if the product can be used over the counter.
MRI Safety Tested
Select Yes if the product has been tested for MRI safety.
MRI Safety Status
If the product has been tested for MRI safety, select the safety status of the MRI testing:
• MR Conditional
• MR Safe
• MR Unsafe
• Labeling does not contain MRI Safety Information
4. Under Production Identifiers, complete the following fields:
Attribute
Description
Lot Controlled
Select Yes to indicate that the device is managed by lot number. This number can be found on the label or packaging material. A lot or batch meets the following criteria:
• One or more components or finished devices that consist of a single type, model, class, size, composition, or software version
• Manufactured under essentially the same conditions
• Intended to have uniform characteristics and quality within specified limits
Serial Controlled
Select Yes to indicate that the device is managed by serial number. This number can be found on the device label or accompanying packaging. It is assigned by the company and should be specific to each device.
Manufacture Date Controlled
Select Yes to indicate that the device is managed by the date a specific device was manufactured.
Expiration Date Controlled
Select Yes to indicate that the device is managed by expiration date. This is the date by which the device label states that the device must or should be used.
Device Count
Enter the number of medical devices in the base package. The base package is the package configuration as labeled with and identified by the primary device identifier. For example, if the base package is a box of 100 gloves, and the primary device identifier is 101, the device count is 100.
5. Under FDA Attributes, complete the following fields:
Attribute
Description
Device Identifier Record Publish Date
Select the date the device identifier record should be published in the public search module. Click the calendar icon to select the completion date for the request. You can also enter the date manually using the YYYY-MM-DD format.
Discontinued Date
Select the date the device was discontinued, if applicable. Click the calendar icon to select the completion date for the request. You can also enter the date manually using the YYYY-MM-DD format.
Exempt from Direct Part Marking
Select Yes if the company can claim that the product is exempt from direct part marking requirements as described under 21 CFR 801.45.
Exempt from Premarket Authorization
Select Yes to indicate that the device is exempt from FDA premarket regulations.
Prescription Use
Select Yes if the product requires a prescription.
Over the Counter Use
Select Yes if the product can be used over the counter.
6. Click Next.
Table Data
Complete the fields in the Table Data step.
1. Under Alternate Identifiers, do the following:
a. Click the add alternate identifier icon .
b. From the Issuing Agency list, select the name of the issuing agency.
c. In the Secondary Device Identifier field, type a secondary device identifier number. This is an alternate lookup for a medical device product. The identifier is issued from a different issuing agency than the primary device identifier.
2. Under Device Contact Information, do one of the following:
◦ Click the add UDI contact icon . In the UDI Contact Picker window, search for and select a contact. Click OK. From the Contact Type list, select Regulatory Contact or Support Contact.
◦ Click the add reported UDI contact to this table icon . From the Contact Type list, select Regulatory Contact or Support Contact. Enter a first name, last name, contact email, contact phone, and phone extension.
◦ Type three or more letters in the Add by Alternate Identifier or Add by Name fields and select a contact from the list. From the Contact Type list, select Regulatory Contact or Support Contact.
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Regulatory contacts are for internal use only; this is a person whom the FDA can contact. Support contacts are consumer or provider contacts for public use.
It is recommended that you use templates to populate device contact information when creating UDIs.
3. Under GMDN and FDA Term Code, do the following:
a. Click the add GMDN and FDA term code icon .
b. Enter the GMDN and FDA term code. GMDN and FDA codes are a defined set of codes managed by the GMDN Agency.
4. Under Sterilization Method section, do one of the following:
◦ Click the add sterilization method icon . In the Sterilization Method Code Picker window, select the sterilization methods and click OK to add them to the table.
◦ Type three or more letters in the Add by Code or Add by Name fields to search for the sterilization method code or name. Select the method to add it to the table.
5. Under Device Size Characteristics, do the following:
a. Click the add device size characteristic icon .
b. Select a size type.
c. Select a unit of measure.
d. Enter a value.
e. Enter a description.
6. Under Storage and Handling Requirements, do the following:
a. Click the add device storage characteristic icon .
b. Select a storage type. This indicates the storage requirements required for the device, such as temperature or humidity.
c. Select a unit of measure.
d. Enter a low value to indicate the low value for storage requirements, such as temperature, humidity, and so on.
e. Enter a high value to indicate the high value for storage requirements, such as temperature, humidity, and so on.
f. Enter a description.
7. Under Packaging Configuration, do the following:
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This option is available for creating and editing UDI submissions and for editing UDI templates, but not for creating UDI templates.
◦ To expand the hierarchy, click the expand icon .
◦ To collapse the hierarchy, click the collapse icon .
◦ To create UDI packaging, click the new UDI packaging icon . In the Create UDI Packaging window, do the following:
1. In the Description field, enter a text description.
2. In the Package Device Identifier field, enter a device identifier for the package configuration that contains multiple units of the base package (not including shipping containers).
▪ This identifier must be unique.
▪ This identifier does not include shipping packages.
▪ For example, if there are 10 glove boxes in a carton, the package device identifier is the UDI on the carton (such as 301). If there are 10 glove boxes in a carton and 5 cartons in a case, the package device identifier is the UDI on the case (such as 201). If there are 5 cartons in a pallet, the package device identifier is the UDI on the pallet (such as 401). The pallet contains 5 cartons with 10 glove boxes in a carton.
3. In the Quantity field, enter the number of packages with a unique primary device identifier within a packaging configuration.
For example, if a package configuration case contains 4 boxes of the base package, the quantity per package is 4. If a package configuration carton contains 10 boxes of the base package, the quantity per package is 10. If a package configuration pallet contains 5 cartons of the base package, the quantity per package is 5.
4. In the Create UDI Packaging window, click Finish.
8. In Details section, click add details icon , this adds details row. Select one of the following options in the row from the drop-down menu:
◦ All Supported Attribute Types
◦ FDA Listing Number
◦ FDA Premarket Authorization
◦ FDA Product Code
Click edit . This opens Edit Details wizard where you can edit all related details.
9. When you complete all information in the Table Data section, click Finish.
UDI Super Set are validated against published rules before moving to the next state. Templates are not validated against published rules.